NEW YORK--(EON: Enhanced Online News)--Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug
Administration (FDA) has accepted for review the supplemental New Drug
Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg
and 10 mg tablets, a Janus kinase (JAK) inhibitor, the first in a new
class of oral medicines being investigated for the treatment of adult
patients with moderate to severe chronic plaque psoriasis who are
candidates for systemic therapy or phototherapy. The FDA has provided an
anticipated Prescription Drug User Fee Act (PDUFA) action date in
October 2015 for the sNDA.

“This regulatory milestone demonstrates our commitment to the research
of chronic inflammatory diseases with the goal of developing therapies,
such as XELJANZ, that can help address unmet medical needs for
patients”

The submission to the FDA is based on data from the Phase 3 Oral
treatment Psoriasis Trials (OPT) Program, a global,
multi-study, comprehensive clinical development program that consisted
of five studies (including an ongoing long-term extension study),
designed to evaluate oral XELJANZ 5 mg and 10 mg twice daily in patients
with moderate to severe chronic plaque psoriasis. With more than 3,600
adult psoriasis patients enrolled across 36 countries, the OPT program
has yielded one of the largest databases for a potential psoriasis
indication at the time of registration.

XELJANZ is a small molecule that targets the JAK pathway, a signaling
pathway inside the cells, thought to play a role in chronic inflammatory
responses.

“This regulatory milestone demonstrates our commitment to the research
of chronic inflammatory diseases with the goal of developing therapies,
such as XELJANZ, that can help address unmet medical needs for
patients,” said Steve Romano, MD, SVP and Head, Global Medicines
Development for the Pfizer Global Innovative Pharmaceutical business.
“We continue to play a leadership role in the evaluation of JAK
inhibition across chronic inflammatory diseases, such as psoriasis.”

XELJANZ is approved in 37 countries around the world for the treatment
of moderate to severe rheumatoid arthritis (RA). In the United States,
XELJANZ 5 mg tablets are approved for the treatment of adults with
moderate to severe RA who have had an inadequate response or intolerance
to methotrexate (MTX). The benefit:risk profile of XELJANZ in RA has
been characterized through the study of 6,192 RA patients representing
16,800 patient years of exposure in the global clinical development
program for XELJANZ in moderate to severe RA.

About Plaque Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory skin disease,
affecting the skin and other parts of the body, such as nails. It
affects approximately two-to-three percent of people worldwide and 7.4
million in the United States.1,2,3,4,5,6,7 The most common
form is plaque psoriasis, which affects about 80 percent of people who
have the condition.8 Of those, as many as 20 percent have
moderate to severe chronic plaque psoriasis.6 A need for
additional therapies remains. According to recently published surveys,
approximately 50 percent of patients with psoriasis are dissatisfied
with their treatment. Under-treatment also represents a significant
problem. Even though guidelines typically state that patients with
moderate to severe psoriasis are candidates for systemic therapy, many
treated adult plaque psoriasis patients appear to be undertreated, with
approximately 30 percent of treated moderate patients and 22 percent of
treated severe patients receiving only topical therapy in the United
States.9

XELJANZ® (tofacitinib citrate) RA U.S. Label
Information

XELJANZ is a prescription medicine called a Janus kinase (JAK)
inhibitor. XELJANZ is used to treat adults with moderately to severely
active rheumatoid arthritis in which methotrexate did not work well.

It is not known if XELJANZ is safe and effective in people with
Hepatitis B or C.

XELJANZ is not for people with severe liver problems.

It is not known if XELJANZ is safe and effective in children.

Important Safety Information

XELJANZ can lower the ability of the immune system to fight
infections. Some people have serious infections while taking XELJANZ,
including tuberculosis (TB), and infections caused by bacteria, fungi,
or viruses that can spread throughout the body. Some people have died
from these infections. Healthcare providers should test patients for
TB before starting XELJANZ, and monitor them closely for signs and
symptoms of TB and other infections during treatment. People should
not start taking XELJANZ if they have any kind of infection unless
their healthcare provider tells them it is okay.

XELJANZ may increase the risk of certain cancers by changing the
way the immune system works. Malignancies were observed in clinical
studies of XELJANZ.

The risks and benefits of treatment should be considered prior to
initiating XELJANZ in patients with chronic or recurrent infection;
who have been exposed to tuberculosis; with a history of a serious or
an opportunistic infection; who have resided or traveled in areas of
endemic tuberculosis or endemic mycoses; or with underlying conditions
that may predispose them to infection.

Use of live vaccines should be avoided concurrently with XELJANZ.
Update immunizations in agreement with current immunization guidelines
prior to initiating XELJANZ therapy.

Some people who have taken XELJANZ with certain other medicines to
prevent kidney transplant rejection have had a problem with certain
white blood cells growing out of control (Epstein Barr
virus-associated post-transplant lymphoproliferative disorder).

Some people taking XELJANZ get tears in their stomach or intestines.
This happens most often in people who also take nonsteroidal
anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Patients should tell their healthcare provider right away if they have
fever and stomach-area pain that does not go away, or a change in
bowel habits. XELJANZ should be used with caution in patients who may
be at increased risk for gastrointestinal perforation (e.g., patients
with a history of diverticulitis).

XELJANZ can cause changes in certain lab test results including low
blood cell counts, increases in certain liver tests, and increases in
cholesterol levels. Healthcare providers should do blood tests before
starting patients on XELJANZ and while they are taking XELJANZ, to
check for these side effects. Normal cholesterol levels are important
to good heart health. Healthcare providers may stop XELJANZ treatment
because of changes in blood cell counts or liver test results.

Use of XELJANZ in patients with severe hepatic impairment is not
recommended.

Patients should tell their healthcare providers if they plan to become
pregnant or are pregnant.

It is not known if XELJANZ will harm an unborn baby. To monitor the
outcomes of pregnant women exposed to XELJANZ, a registry has been
established. Physicians are encouraged to register patients and pregnant
women are encouraged to register themselves by calling 1-877-311-8972.

Patients should tell their healthcare providers if they plan to
breastfeed or are breastfeeding. Patients and their healthcare
provider should decide if they will take XELJANZ or breastfeed. They
should not do both.

In carriers of the hepatitis B or C virus (viruses that affect the
liver), the virus may become active while using XELJANZ. Healthcare
providers may do blood tests before and during treatment with XELJANZ.

At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. To learn more, please visit us at www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of
February 4, 2015. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.

This release contains forward-looking information about a potential
new indication for XELJANZ (tofacitinib citrate) for the treatment of
adult patients with moderate-to-severe chronic plaque psoriasis,
including its potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research and
development, including, without limitation,the possibility of
unfavorable clinical trial results, including unfavorable new clinical
data and additional analyses of existing clinical data; whether and when
any applications may be filed with regulatory authorities in other
jurisdictions for XELJANZ for the potential treatment of
moderate-to-severe chronic plaque psoriasis; whether and when the FDA
may approve the supplemental new drug application and whether and when
regulatory authorities in other jurisdictions may approve any such other
applications, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted; decisions by regulatory
authorities regarding labeling and other matters that could affect the
availability or commercial potential of XELJANZ; and competitive
developments.

A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2013 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information That May Affect Future Results”, as well as in its
subsequent reports on Form 8-K, all of which are filed with the SEC and
available at www.sec.gov
and www.pfizer.com.

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